EFS of Posterior Leaflet Replacement to Reduce Mitral Regurgitation (United States)

Inclusion criteria

• Patient has symptomatic moderate-to-severe to severe functional mitral regurgitation despite stable doses of maximally tolerated guideline directed medical therapy (GDMT) per the Local Heart Team.

Note: In the 30 days prior to performing screening assessments, no new GDMT medications should be introduced and current doses should be stable (i.e. no decrease of > 50% or increase of > 100%) excluding diuretics. Any changes beyond this range would not be considered stable GDMT.

• Functional MR graded 3+ or higher (using a scale of 0 to 4+) by transthoracic echocardiography (TTE) within 60 days prior to study procedure as evaluated by the sponsor's Echo Core Lab.
• New York Heart Association (NYHA) Functional Class II, III or ambulatory IV heart failure
• Patient must present with an STS Score less than 10% and deemed by the Local Heart Team to be at high risk but operable for mitral valve surgery.
• The Local Heart Team deems the patient unsuitable for commercially approved transcatheter mitral valve therapies
• 21 years of age or older
• Native mitral valve geometry and size is compatible with the Polares MRace system
• Anatomy is suitable for transfemoral transseptal access with the Polares MRace system
• Patient is willing to participate in study and provides signed IRB/EC-approved informed consent
• Treating physician and patient agree that patient is able to return for all required post-procedure follow-up visits
• Patient is approved by an independent Patient Eligibility Committee

Exclusion criteria

• Echocardiographic parameters (any of the following, assessed by the Echo Core Lab)

• Left ventricular ejection fraction (LVEF) < 30%
• Pulmonary artery systolic pressure (PASP) > 70mmHg or > 2/3 SBP (Systolic Blood Pressure)
• Left Ventricle End Diastolic Volume (LV EDV) > 200 mL
• Left Ventricle End Systolic Volume (LV ESV) > 140 mL
• Left Ventricle End Diastolic Diameter (LV EDD) > 70 mm
• Left Ventricle End Systolic Diameter (LV ESD) > 55 mm
• Severe Right Ventricle (RV) dysfunction as per assessment by Local Heart Team or Eligibility Committee .
• Severe tricuspid regurgitation.
• Severe aortic stenosis or insufficiency.
• Severe mitral annulus calcification.
• Diseased mitral anterior and/or posterior leaflet, such as flail, / prolapse, or/ heavy moderate to severe calcification.
• Barlow's disease.
• Presence of an implanted vena cava filter or any other device (e.g. ASD closure device) that may interfere with femoral vein access or delivery system access to the mitral valve.
• Contraindication for transesophageal echocardiography (TEE) or MDCT scan
• Active infection or endocarditis or infection requiring antibiotic therapy within 2 weeks of scheduled procedure.
• Previous mitral valve surgery or transcatheter mitral valve procedure.
• Prior orthotopic heart transplantation.
• Evidence of intra-cardiac, inferior vena cava (IVC) or femoral venous thrombus. History of deep vein thrombosis (DVT) or pulmonary embolism within 6 months of the index procedure.
• Untreated Class I indication for pacing (CRT). Implant or revision of any pacing device < 30 days prior to intervention
• Any untreated clinically significant coronary artery disease requiring revascularization. Coronary, carotid, or endovascular artery disease treated percutaneously < 30 days prior to study procedure. Cardiac surgery < 90 days prior to study procedure.
• Myocardial infarction requiring intervention < 30 days prior to study procedure
• Infiltrative cardiomyopathies (e.g., amyloidosis, hemochromatosis, sarcoidosis), hypertrophic or restrictive cardiomyopathies, and constrictive pericarditis)
• Active peptic ulcer or upper gastrointestinal bleeding < 90 days prior to study procedure.
• Stroke < 180 days prior to study procedure.
• Severe COPD requiring oral steroid therapy or oxygen therapy.
• Severe renal insufficiency (creatinine > 3.0 mg/dL) or patient requiring dialysis
• Cardiogenic shock at time of enrolment. Hemodynamic instability requiring inotropic support or mechanical heart assistance.
• Concurrent medical condition with a life expectancy of less than 2 years
• Pregnancy or breastfeeding at time of enrolment with a positive pregnancy test within 14 days of study procedure.
• History of bleeding diathesis or coagulopathy or leukopenia (WBC < 3,000 mcL) or acute anemia (Hb < 9 g/dL) or thrombocytopenia (platelets < 50,000 cells mcL)
• Known hypersensitivity or contraindication to aspirin, heparin, ticlopidine or clopidogrel, nitinol, tantalum or allergy to contrast agents that cannot be pre-medicated.

Note. Patient must be able to tolerate at least one antiplatelet medication AND one anticoagulant medication.

• Severe dementia or lack of capacity due to conditions that result in either inability to provide informed consent for the trial/procedure, prevent independent lifestyle outside of a chronic care facility, or will fundamentally complicate rehabilitation from the procedure or compliance with follow-up assessments.
• Patient is in need for emergent or urgent surgery for any reason or any planned cardiac surgery within the next 12 months.
• Company employees or their immediate family members.
• Patient is considered to be part of a vulnerable population, is under guardianship, or subject to any other medical, social or psychological conditions that preclude appropriate consent and follow-up.
• Patient is participating in another clinical study for which follow-up is currently ongoing.